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Completed

NCT Number: NCT02714127

Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Wiebren Tjalma

Edegem, Antwerp, 2650, Belgium

About this study

In total 100 women will be included in this trial, women diagnosed with abnormal cytology results and/or high risk HPV (Human Papillomavirus) infection scheduled for a colposcopy exam. These women are asked to collect a first-void urine sample with the Colli-PeeTM device, prior to their colposcopy exam at the clinic. The collected urine samples will be used for the development and optimisation of robust analytical protocols for first-void urine sample preparation and biomarker assays.

During colposcopy, the cervix will be visually inspected, whether or not combined with a biopsy for histological confirmation. Colposcopy is a procedure to identify abnormalities by using a colposcope that gives an illuminated, magnified view of the cervical region. It often includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). Here, this fluid will be collected and serve as the intermediate step between biomarkers in cervicovaginal secretions and urine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 25-64 year old
  • Women scheduled for a colposcopy exam due to abnormal cytology result according to the Bethesda classification 2001 (NILM, AGC (Atypical Glandular Cells), ASC-US (Atypical Squamous Cells of Undetermined Significance), ASC-H (Atypical Squamous Cells - cannot exclude HSIL), LSIL (Low-grade Squamous Intraepithelial Lesion), HSIL (High-grade Squamous Intraepithelial Lesion), invasive carcinoma), and/or positive for hrHPV infection. NILM (Negative for Intraepithelial Lesion or Malignancy) are only included when positive for hrHPV infection.
  • Signing informed consent form (ICF).
  • Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).

Exclusion criteria

  • Participating in another clinical study at the same time of participating in this study.
  • Not able to understand the information brochure/what the study is about.
  • Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Treatment and study plan

First-void urine collection

Other

One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).

Other names: FV urine

Cervicovaginal lavage fluid collection

Other

During colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.

Other names: VagLav

Primary outcomes

  1. Concentration of cervical cancer biomarkers in first-void urine

    Time frame: Within 6 months after study completion

    To detect candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in first-void urine samples from 100 women scheduled for colposcopy due to abnormal cytology.

Secondary outcomes

  1. Preference of women for self-sampling methods

    Time frame: Within 6 months after study completion

    Gather information about the preference of women for first-void urine sample collection compared to the currently available self-sampling methods, and a clinician collected sample (smear).

  2. Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine

    Time frame: Within 6 months after study completion

    To compare the presence of candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in paired first-void urine and VagLav samples from 100 women scheduled for colposcopy due to abnormal cytology.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Research Foundation Flanders
  • University Hospital, Antwerp

Registry information

Official study title

Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine: the BM-SOP Study

Acronym: BM-SOP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2016
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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